Pre-Clinical

The following services are offered as either stand-alone activities or as part of a more extensive development effort:

Synthetic Organic Chemistry / API:

• Route Selection
• Evaluation of existing routes to leads, scaffolds and development candidates, from point of view of safety and practicality
• Troubleshooting and adaptation of synthetic routes for scale-up
• Development of new synthetic routes or steps, as warranted

Chemical Process Development:

• Scale-up and production of leads and candidates for preclinical R&D, including IND-enabling tox batch
• Selection of appropriate API physical form
• Pharmaceutical salt screening, evaluation, selection and development
• GMP manufacture to provide clinical API supply
• Chemical process R&D – process optimization, process discovery, asymmetric synthesis
• Critical process impurity tracking and control

Radiosynthesis:

• Design of routes to radiolabeled leads and APIs for nonclinical research (non-GMP synthesis) and clinical studies (GMP synthesis)

Analytical Support / Material Characterization:

• Development of fit-for-purpose methods for reaction monitoring, intermediate and product purity
• Selection/development of release tests for IND-enabling nonclinical and clinical GMP API lots produced/manufactured
• Characterization
• Structure verification
• Physicochemical/solid state properties crystallinity, polymorphism, solubility
• Critical impurity detection, quantification and identification
• Potential Genotoxic Impurities (PGIs) – prediction, identification, quantification and control
• Stability – supporting non-regulated preclinical evaluations and formal (GMP) studies

Formulation:

• Development of nonclinical toxicology formulations
• Preformulation studies
• Development, selection and production/manufacture of clinical formulations

Regulatory CMC:

• Preparation and execution of strategies for transition of lead molecules, from late discovery through candidate nomination, preclinical R&D and clinical trials
• Selection and justification of API regulatory starting materials for GMP manufacture
• Authorship and review of new chemical entity (NCE) investigative new drug (IND) CMC sections

The pharmaceutical sciences team utilise a wide network of established service providers to deliver support in the following areas to optimise the quality, cost and speed of collaborative research.

Pre-formulation

• Strategic sourcing of vendors to provide pre-formulation, formulation development and analytical solutions for pre-clinical, toxicological and clinical studies
• Technical evaluation of early lead molecules to risk assess pharmaceutical delivery and development options
• Project and relationship management
• Developing and ensuring execution of work plans to deliver high quality results

Program Management

• Application of expertise in the discovery and development new medicines
• Developing program strategy options, which efficiently address needs and capitalise on opportunities
• Building and delivering on effective plans, in line with individual client and compound needs
• Facilitation of problem solving, decision analyses and stakeholder management
• Risk identification and development of mitigation strategies
• Harmonising services to deliver key milestones

The TRN ADME/DMPK team utilise a wide network of established service providers to deliver support in the following areas to optimise the quality, cost and speed of collaborative research:

• Access to a wide range of non-GLP and GLP ADME assays
• Vendor identification/selection.
• Service agreement/work order generation
• Negotiating competitive quotes, scheduling, prioritisation and deliverables (timelines and output required)
• Study design expertise
• Study placement support – from compound shipment to data upload
• Information transfer (study, methods, compound)
• Watson study generation
• Scientific troubleshooting
• Data transfer, review & storage (online services, Secure email, etc)
• Timeline tracking
• Market scan/research
• Vendor audits and assessment (scientific and business)
• Relationship management

The TRN regulatory team can help with all aspect of your regulatory affairs from discovery to commercialization across all therapeutic areas. Our highly experienced team can help with:

• Managing and optimizing communication with regulatory authorities, enabling clients to work more effectively and reducing time to registration/marketing
• Meeting your specific regulatory needs with global agencies. From getting human clinical trails started to registering new medicines, variations or updates to exiting ones
• Submission management: Our team has a proven record in every aspect of global electronic and paper document preparation and assembly, including extensive expertise in compiling documentation to support clinical trials and registration dossiers.
• Project leadership: we can help to ensure compliance with global regulations and enable the understanding and interpretation of the dynamic global regulatory landscape

Achieving Customer Goals

• We can provide advice, consultancy and problem solving to enable:
• IND / CTA filing for 1st in human studies
• New drug / marketing authorisation applications

Why choose the TRN Regulatory team?

• We have a team of experts who work cohesively together
• We work in collaboration with trusted network partners and associates
• We have individual experts with established blue chip credentials and SME experience
• We can harness the benefits of big pharma expertise and matrixed teams
• We have established good relationships with regulators
• We can provide operational support of electronic filings
• We are geographically and linguistically close to FDA, EMEA, HC and TGA

The TRN Global Study Monitoring Team has extensive experience in the areas of: Toxicology, Safety Pharmacology, DMPK and Pathology. Located in the EU and US with strong connections in India and China, the team can help you by offering the following services:

What We Deliver

• Scientific QC Review or reports & preparation of regulatory submission documentation
• CRO selection
• CRO auditing
• Protocol design
• Study Monitoring
• Data review & QC
• Pathology peer review (Board Certified)
• Preparation and review of reports
• Scientific review
• Pathology review of reports
• QA if needed via specialist CRO partners
• Preparation and review of regulatory documentation

What is Unique About GSM?

• Global presence and perspective
• Integrated across key disciplines
• Ability to rapidly deliver all aspects of project work
• Single contract – rapid, flexible & cost effective response
• Integrated study design, troubleshooting cross-discipline

Why Choose GSM?

Five reasons to choose GSM for your integrated study monitoring:

1. Interactive team that will work with you to drive your project(s) forward
2. Extensive study monitoring expertise
3. Reduced travel and inconvenience
4. Study designs tailored to your needs
5. Global perspective and connections

The TRN drug safety team provide access to a range of service providers and consultants to deliver support in the following areas:

Safety Pharmacology

• Design and management of GLP-compliant safety pharmacology and supplemental safety pharmacology studies
• Advice on potential target/mechanism related and compound safety pharmacology liabilities
• Access to and interpretation of broad ligand profiling panels for assessing the potential to cause off-target effects
• CRO selection, protocol design, study oversight, report review and subject matter expertise for outsourced studies
• Preparation of regulatory documentsExtrapolation of safety pharmacology findings to man and assessment of risk/benefit

Toxicology

• Design and management of toxicology studies including GLP compliance oversight
• Investigative / supplemental toxicology tests
• CRO selection
• Protocol design, study oversight, report review and broad subject matter expertise for outsourced studies
• Preparation of regulatory documents
• Extrapolation of toxicology findings to man and assessment of risk/benefit

Pathology

• Toxicologic Pathology (study design, protocol review, study monitoring and necropsy supervision)
• Pathology peer review and primary interpretation of gross, microscopic, and clinical pathology data from toxicology studies
• Toxicological risk assessment and interaction with government regulatory authorities

The TRN statistics and decision support team can be engaged to optimize the value of your drug discovery program. Decision analysis enables project managers to identify the most efficient strategy to apply to an individual project, cluster of projects or portfolio.

Statistical expertise ensures the maximum information is obtained from experiments given the available resources and the resulting data is appropriately analysed to differentiate true signal from noise.